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Trial record 10 of 133 for:    Complex Regional Pain Syndrome

Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03111225
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Reuth Research Institute, Reuth Medical Center

Brief Summary:
This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.

Condition or disease Intervention/treatment Phase
Complex Regional Pain Syndromes Diagnostic Test: massage Not Applicable

Detailed Description:

This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. The muscles that will be examined are: Subclavius, Pectoralis minor, Rhomboids, Infraspinatus and Serratus superior posterior.

In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.This will be examined in an A-B-A design: at first the patients will be examined. Then they will recieve conventional physiotherapy treatment for a month. After a month, they will be examined again, and then they will recieve soft tissue massage to the thoracic area for 15 minutes in addition to the conventional physiotherapy treatment. After a month of the combined treatment, the patients will be examined a third and final time.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The observation stage is a case- control study, the treatment stage is an A-B-A design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome
Actual Study Start Date : June 6, 2016
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : October 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CRPS patients
CRPS patients that will be examined for trigger points in the thoracic muscles. 10 out of the 23 will also be included in the intervention stage and will recieve a month of conventional physiotherapy, and a month of conventional physiotherapy with addition of massage to the thoracic area.
Diagnostic Test: massage
a 15 minutes thoracic massage will be added to the regular physical therapy treatment

No Intervention: healthy controls
healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)



Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire [ Time Frame: 10 minutes ]
    Questionnaire that examines upper limb function


Secondary Outcome Measures :
  1. Goniometer [ Time Frame: 1 minute ]
    shoulder flexion range of motion

  2. CRPS severity score (CSS) [ Time Frame: 20 minutes ]
    form filled by an MD after an interview and examination of a patient

  3. skin rolling test [ Time Frame: 1 minute ]
  4. trigger point examination [ Time Frame: 5 minutes ]
  5. NPRS [ Time Frame: 1 minute ]
    Numerical Pain Rating Scale

  6. Pressure algometer [ Time Frame: 10 minutes ]
    pressure pain threshold

  7. Allodynia in scapula, arm and forearm [ Time Frame: 5 minutes ]
    von Frey filaments



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusions Criteria for "cases" in stage 1 and all subjects of stage 2:

  • Age between 18-70
  • CRPS diagnosed by board certified specialist in rehabilitation or pain medicine
  • Constant chronic pain for ≥six months preceding the trial;
  • Spontaneous pain in a day of first evaluation (numeric pain rating scale (NPRS) ≥4/10)
  • Stimulated pain is not attributable to other causes, such as peripheral inflammation.

Inclusions Criteria for "controls" in stage 1:

  • Age between 18-70
  • Do not suffer from any medical issues or chronic pain

Exclusion criteria for all subjects in stages 1 and 2:

  • Tumors
  • Participation in another interventional clinical trial.
  • History of major psychiatric or neurological illness (like stroke).
  • Rheumatoid arthritis or other major rheumatologic disorders.
  • Fibromyalgia or any other systemic illness.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111225


Contacts
Contact: Adi Dor, BPT 97236383720 adi.dor@reuth.org.il
Contact: Sara Sultan, PhD 97236893788 Research_info@reuth.org.il

Locations
Israel
Reuth rehabilitation medical center Recruiting
Tel Aviv, Israel
Contact: Jean-Jacques Vatine, Professor    97236383679    vatinejj@reuth.org.il   
Contact: Sara Sultan, PhD    97236893788    Research_info@reuth.org.il   
Sponsors and Collaborators
Reuth Medical Center
Investigators
Principal Investigator: Jean-Jeaques Vatine, Prof Reuth Rehabilitation Hospital

Responsible Party: Reuth Research Institute, Professor, Reuth Medical Center
ClinicalTrials.gov Identifier: NCT03111225     History of Changes
Other Study ID Numbers: 2016-2
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases